Alzheimer DiseaseDiMENCT06242574
Meaningful Aspects of Health for Adults With Dementia, Their Care Partners and Healthcare Practitioners
An observational study of Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Survey
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with ADRD, their care givers and Health-care practitioners
Adults with Alzheimer's disease and related dementia:
- ADRD inclusive of the following :
- Mild dementia due to Alzheimer's disease inclusive of:
- Mild Cognitive Impairment (MCI),
- Prodromal Alzheimer's disease,
- Subjective cognitive impairment,
- Early onset dementia due to Alzheimer's disease,
- Mild Alzheimer's Disease
- Frontotemporal dementia (FTD) - Frontal variant
- Frontotemporal dementia (FTD) - Primary progressive aphasia
- Lewy Body dementia (LBD)
- Vascular dementia
- Ability to read, understand and express non opposition
- Aged 50 years or older
- Patient affiliated to the social security system
Care partners:
- Unpaid care partners for adults with Alzheimer's disease and related dementia ■ A care partner is the primary person who cares for an adult with ADRD, including but not limited to partner, spouse, family member, or significant other of the individual with ADRD. Care partners will be recruited where they care for patients with:
- Mild dementia due to Alzheimer's disease (inclusive of Mild Cognitive Impairment (MCI), Prodromal Alzheimer's disease, Subjective cognitive impairment, Early onset dementia due to Alzheimer's disease, Mild Alzhiemer's Disease )
- Moderate to severe dementia due to Alzheimer's disease
- Frontotemporal dementia (FTD) - Frontal variant
- Frontotemporal dementia (FTD) - Primary progressive aphasia
- Lewy Body dementia (LBD)
- Vascular dementia
- Delivers at least 10 hours of additional care per week since diagnosis
- Ability to read, understand and express non opposition
- Aged 18 years or older
- Subject affiliated to the social security system
Health-care practitioners
- Healthcare practitioners actively treating adults with ADRD, including: neurologists, geriatricians, psychiatrists, neuropsychologists and social workers
- Currently treats a minimum of 10 ADRD patients
- express non opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed-methods Study to Identify Meaningful Aspects of Health for Adults With Dementia, Their Care Partners and Healthcare Practitioners
The aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals. Commonalities and differences between these three stakeholders and according to the severity of the dementia will also be studied.
Read the detailed description
Alzheimer's disease and related disorders (ADRD) are the sixth leading cause of death among adults. Currently, more than 55 million people worldwide are living with the disease, with nearly 10 million new cases each year. ADRD causes significant economic and care burdens for thousands of families and their communities, with over 60% of caregivers developing depressive symptoms. ADRD is ranked among the most costly diseases for society . It is therefore necessary to intervene in order to combat this devastating disease. As recent guidance from the Food and Drug Administration indicates, there is a need to identify areas and mechanisms for real-world change to improve patients' quality of life.
The European Medicines Agency Expert Advisory Group concluded that there was no consensus on validated outcomes in early-stage ADRD and identified the need to fill these gaps.
To demonstrate the utility of any clinical outcome assessment, it's important to link these measures to real-world experiences. And to create this link, research is needed to better understand the meaningful aspects of the health of Alzheimer's patients and their caregivers. In addition, it is important to understand how these MAHs relate to clinicians' perspectives and their approach to assessing disease severity.
Thus, the aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals.
Participants with Alzheimer's disease and related dementia and caregivers will be recruited through the Memory Clinic at the Geriatric Hospital in Nice.
Healthcare practitioners working at Centre de Mémoire de Ressources et de Recherche, or outside the Centre , and actively treating a minimum of 10 adults with ADRD, including: neurologists, geriatricians, psychiatrists, neuropsychologists and social workers will be proposed to participate.
All participants will be given a web link to access the survey and will complete it remotely. The survey will take approximately 30 minutes to complete.
- Conditions
- Alzheimer Disease
- Being tested
- Survey
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Each group will have to complete a questionnaire online, taking about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Alzheimer's disease and related dementia | 75 patients with ADRD Receives: Other: Survey | |
| Care partners of Adults with Alzheimer's disease and related dementia | 75 care partners for adults with ADRD Receives: Other: Survey | |
| Clinicians who treat patients with Alzheimer's disease and related dementia | 25 healthcare practitioners Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the meaningful aspects of health that patients, care partners and clinicians consider most important when considering improvement in the ADRD patient's condition and when considering prevention of decline in the ADRD patient's condition
questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions
Measured: day 1
Assessment of the meaningful aspects of health that patients, care partners and clinicians consider most important when considering prevention of decline in the ADRD patient's condition
questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Apr 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Why it stopped: Submission to EC abandonned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242574
- Sponsor's protocol ID
- 23-PP-11
- Acronym
- DiME
- Status last verified
- Sep 2024
- First submitted
- 19 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-methods Study to Identify Meaningful Aspects of Health for Adults With Dementia, Their Care Partners and Healthcare Practitioners
- ClinicalTrials.gov ID
- NCT06242574
- Acronym / sponsor ID
- DiME / 23-PP-11
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Submission to EC abandonned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals. Commonalities and differences between these three stakeholders and according to the severity of the dementia will also be studied.
Detailed description
Alzheimer's disease and related disorders (ADRD) are the sixth leading cause of death among adults. Currently, more than 55 million people worldwide are living with the disease, with nearly 10 million new cases each year. ADRD causes significant economic and care burdens for thousands of families and their communities, with over 60% of caregivers developing depressive symptoms. ADRD is ranked among the most costly diseases for society . It is therefore necessary to intervene in order to combat this devastating disease. As recent guidance from the Food and Drug Administration indicates, there is a need to identify areas and mechanisms for real-world change to improve patients' quality of life.
The European Medicines Agency Expert Advisory Group concluded that there was no consensus on validated outcomes in early-stage ADRD and identified the need to fill these gaps.
To demonstrate the utility of any clinical outcome assessment, it's important to link these measures to real-world experiences. And to create this link, research is needed to better understand the meaningful aspects of the health of Alzheimer's patients and their caregivers. In addition, it is important to understand how these MAHs relate to clinicians' perspectives and their approach to assessing disease severity.
Thus, the aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals.
Participants with Alzheimer's disease and related dementia and caregivers will be recruited through the Memory Clinic at the Geriatric Hospital in Nice.
Healthcare practitioners working at Centre de Mémoire de Ressources et de Recherche, or outside the Centre , and actively treating a minimum of 10 adults with ADRD, including: neurologists, geriatricians, psychiatrists, neuropsychologists and social workers will be proposed to participate.
All participants will be given a web link to access the survey and will complete it remotely. The survey will take approximately 30 minutes to complete.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults with Alzheimer's disease and related dementia | – | Other: Survey75 patients with ADRD |
| Care partners of Adults with Alzheimer's disease and related dementia | – | Other: Survey75 care partners for adults with ADRD |
| Clinicians who treat patients with Alzheimer's disease and related dementia | – | Other: Survey25 healthcare practitioners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with ADRD, their care givers and Health-care practitioners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyEach group will have to complete a questionnaire online, taking about 30 minutes. | Other | Adults with Alzheimer's disease and related dementia, Care partners of Adults with Alzheimer's disease and related dementia, Clinicians who treat patients with Alzheimer's disease and related dementia |
Primary outcome
Assessment of the meaningful aspects of health that patients, care partners and clinicians consider most important when considering improvement in the ADRD patient's condition and when considering prevention of decline in the ADRD patient's condition
Time frame: day 1
questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions
Assessment of the meaningful aspects of health that patients, care partners and clinicians consider most important when considering prevention of decline in the ADRD patient's condition
Time frame: day1
questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the meaningful aspects of health that patients, care partners and clinicians consider most important when considering improvement in the ADRD patient's condition and when considering prevention of decline in the ADRD patient's condition (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.